IRISS (ILUVIEN Registry Safety Study)

• Research type

  Research Study

• Full title

  An open label, registry study of the safety of ILUVIEN® (fluocinolone acetonide 190 micrograms intravitreal implant in applicator)

• IRAS ID

  143644

• Contact name

  Usha Chakravarthy

• Contact email

  u.chakravarthy@qub.ac.uk

• Sponsor organisation

  Alimera Sciences Limited

• Research summary

  Summary of Results:
  The Iluvien registry study was undertaken to asses the risk profile for ILUVIEN when this treatment became available for routine use. Over 500 patients with diabetic macular oedema were treated with Iluvien and followed up over a minimum period of 3 years. Because Iluvien is a steroid there were rises in intraocular pressure rises that were similar to those identified in original registry trials . After ILUVIEN treatment patients experienced improvements in visual acuity . These findings provide reassurance of the safety of this treatment after introduction into routine clinical care.

• REC name

  HSC REC B

• REC reference

  14/NI/0002

• Date of REC Opinion

  26 Mar 2014

• REC opinion

  Further Information Favourable Opinion